Aptima SARS-CoV-2 Assay
FDA 510(k) K243396 · Hologic, Inc.
510(k) numberK243396
Submission
- Device name
- Aptima SARS-CoV-2 Assay
- Applicant
- Hologic, Inc.
San Diego, CA, US - Received
- October 31, 2024
- Decision date
- February 13, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QQX – Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3981
- Specialty
- Microbiology
A device to detect and identify nucleic acid targets in respiratory specimens from SARS-CoV-2 that cause COVID-19 is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 nucleic acid targets in human clinical respiratory specimens from patients suspected of COVID-19 based on signs and symptoms of respiratory infections by their healthcare providers. The…
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Questions and answers
When was Aptima SARS-CoV-2 Assay cleared by the FDA?
Aptima SARS-CoV-2 Assay (K243396) received a 510(k) decision of Substantially Equivalent on February 13, 2025, 105 days after the submission was received.
What is the product code of K243396?
The FDA product code is QQX – Respiratory Specimen Nucleic Acid Sars-Cov-2 Test, a Class II (moderate risk) device regulated under 21 CFR 866.3981.